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European Medicines Agency Validates Gilead’s Marketing Application for Tenofovir Alafenamide (TAF) for the Treatment of Chronic Hepatitis
– High Rates of Viral Suppression and Improved Renal and Bone Safety Parameters Compared to Viread in Phase 3 Studies –

FOSTER CITY, Calif.--(BUSINESS WIRE)--Feb. 25, 2016-- Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the company’s Marketing Authorization Application (MAA) for tenofovir alafenamide (as fumarate) (TAF) 25 mg – an investigational, once-daily treatment for adults with chronic hepatitis B virus (HBV) infection – has been fully validated and is now under assessment by the European Medicines Agency (EMA).

TAF is a novel, targeted prodrug of tenofovir that has demonstrated high antiviral efficacy similar to Gilead’s Viread® 245 mg of tenofovir disoproxil (as fumarate) (TDF) at one-tenth of the dose. TAF also demonstrated improvements in surrogate laboratory markers of renal and bone safety compared to TDF in clinical trials.

“Chronic hepatitis B infection is a major health concern in Europe, with 14 million people living with the disease and more than 1 million Europeans newly infected with the virus each year,” said Norbert Bischofberger, PhD, Executive Vice President, Research and Development and Chief Scientific Officer, Gilead Sciences. “The validation of this application represents the latest step in our continued efforts to advance the care of people living with progressive liver diseases like HBV.”

The MAA for TAF is supported by 48-week data from two Phase 3 studies which met their primary objective of non-inferiority in efficacy (HBV DNA < 29 IU/mL at week 48) compared to TDF among treatment-naïve and treatment-experienced adults with HBeAg-negative and HBeAg-positive chronic HBV. In both studies, treatment with TAF showed a statistically significant increase in serum alanine aminotransferase normalization relative to the TDF arms when using the American Association for the Study of Liver Disease criteria. Changes in renal and bone laboratory safety parameters favored the TAF treatment regimen. Overall, patients receiving TAF experienced a significantly smaller mean percentage decrease from baseline in hip and spine bone mineral density at week 48 compared to patients receiving TDF. Additionally, the overall median change in serum creatinine from baseline to week 48 favored TAF. Rates of discontinuations due to adverse events and the most commonly reported adverse events were similar in patients receiving TAF or TDF.

TAF for the treatment of HBV will be reviewed by the EMA under the centralized licensing procedure which, if authorized, provides marketing authorization in all 28 member states of the European Union, Norway and Iceland. Gilead also submitted a New Drug Application to the U.S. Food and Drug Administration (FDA) for TAF on January 11, 2016.

TAF as a single agent treatment for HBV is an investigational product and its safety and efficacy have not been established.
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Source: press release, 2/25/16. http://investors.gilead.com/phoenix.zhtml?c=69964&p=irol-newsArticle&ID=...

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Compound/DeviceSpecialtyIndicationCompound ClassTarget
Tenofovir alafenamide (TAF) (GS-7340) Hep BInfectious DiseaseHepatitis B infection (chronic)nucleotide reverse transcriptase inhibitorReverse transcriptase

Mechanism of action: Tenofovir alafenamide (TAF) (GS-7340), a SM, nucleotide analogue reverse transcriptase inhibitor (nRTI). Tenofovir alafenamide inhibits the transcription of viral RNA into DNA. It is a novel prodrug of tenofovir.

Phase of Development: Filed

Event Type: Regulatory EMA: CHMP Opinion (Estimate)

Dates: 2017-03-24

Results:

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European Commission Grants Marketing Authorization for Gilead’s Vemlidy® (Tenofovir Alafenamide, TAF) for the Treatment of Chronic Hepatitis B Virus Infection
-- Vemlidy® is the First New Treatment for Chronic Hepatitis B Infection to be Approved in the European Union in Nearly a Decade --

FOSTER CITY, Calif.--(BUSINESS WIRE)--Jan. 11, 2017-- Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the European Commission has granted marketing authorization for Vemlidy® (tenofovir alafenamide, TAF) 25 mg, a once-daily tablet for the treatment of chronic hepatitis B virus (HBV) infection in adults and adolescents (aged 12 years and older with body weight at least 35 kg).

The marketing authorization allows for the marketing of TAF in the 28 countries of the European Union, Norway and Iceland.

“As the first new treatment for chronic hepatitis B to be approved in Europe in nearly a decade, this approval marks a step forward in the management of a progressive, life-threatening disease affecting 13 million Europeans,” said Professor Pietro Lampertico, Head of the Gastroenterology and Hepatology Division at the Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico, University of Milan, Italy. “Treating a lifelong disease such as chronic hepatitis B can present challenges as patients age, and the improvements in bone and renal laboratory safety parameters demonstrated by TAF compared to TDF allow it to provide an important new option for patients.”

TAF is a novel, targeted prodrug of tenofovir that has demonstrated antiviral efficacy similar to Gilead’s Viread® (tenofovir disoproxil fumarate, TDF) 245 mg, but at one-tenth the dose. Data show that because TAF has greater plasma stability and more efficiently delivers tenofovir to hepatocytes (cells of the liver) compared to TDF, it can be given at a lower dose, which means there is less tenofovir in the bloodstream. By reducing exposure to tenofovir, TAF is associated with improved renal and bone laboratory safety parameters compared to TDF in clinical trials.

“TAF reflects Gilead’s ongoing commitment to improve and simplify care for people with chronic infectious diseases, including hepatitis B, while we continue our research efforts for curative treatments,” said Norbert Bischofberger, PhD, Executive Vice President, Research and Development and Chief Scientific Officer, Gilead Sciences. “We look forward to making TAF available as quickly as possible throughout the European Union.”

TAF’s approval is supported by 48-week data from two international Phase 3 studies (Studies 108 and 110) in 1,298 adult chronic HBV patients. Study 108 randomized 425 HBeAg-negative patients to receive either TAF or TDF, and Study 110 randomized 873 HBeAg-positive patients to receive either TAF or TDF. Both studies met their primary endpoint of non-inferiority to TDF based on the percentage of patients with chronic hepatitis B with plasma HBV DNA levels below 29 IU/mL at 48 weeks of therapy. Patients in the TAF arm of the trials also experienced numerically higher rates of normalization of blood serum alanine aminotransferase (ALT) levels. Both studies showed TAF and TDF to be well-tolerated by patients and discontinuations due to adverse events were 1% and 1.2%, respectively. The most common reported adverse events with TAF were diarrhea, vomiting, nausea, abdominal pain, abdominal distension, flatulence, fatigue, headache, dizziness, rash, pruritus, increased ALT and arthralgia.

While the primary efficacy assessment was performed at week 48, data show that at week 72 viral suppression as well as biochemical responses were maintained with continued TAF treatment. The safety assessment includes analyses performed at both week 48 and week 72 of treatment (median duration of exposure of 88 weeks), and safety endpoints included changes from baseline in bone mineral density at the hip and spine, and changes from baseline in serum creatinine and in eGFR, key indicators of renal health. In both studies, at weeks 48 and 72, changes in renal and bone laboratory safety parameters favored the TAF treatment groups.

Vemlidy was approved by the U.S. Food and Drug Administration on November 10, 2016 for the treatment of chronic HBV infection in adults with compensated liver disease, and by the Japanese Ministry of Health, Labour and Welfare on December 19, 2016 for the suppression of viral replication in chronic hepatitis B patients with evidence of hepatitis B virus replication and abnormal liver function.

For important safety information for TAF in Europe, including posology and method of administration, special warnings, drug interactions and adverse drug reactions, please see the European Summary of Product Characteristics (SmPC) for Vemlidy, available from the EMA website at http://www.ema.europa.eu. The full prescribing information for TAF in the United States, including BOXED WARNING, is available at www.gilead.com.
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Source: press release, 1/11/17. http://investors.gilead.com/phoenix.zhtml?c=69964&p=irol-newsArticle&ID=...

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European CHMP Adopts Positive Opinion for Gilead’s Vemlidy® (Tenofovir Alafenamide, TAF) for the Treatment of Chronic Hepatitis B Virus Infection
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-- Vemlidy Demonstrated Similar Efficacy with Improvements in Renal and Bone Laboratory Safety Parameters Compared to Viread in Phase 3 Studies --

FOSTER CITY, Calif.--(BUSINESS WIRE)--Nov. 11, 2016-- Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMA), has adopted a positive opinion on the company’s Marketing Authorization Application (MAA) for Vemlidy® (tenofovir alafenamide, TAF) 25 mg, an investigational, once-daily tablet for the treatment of chronic hepatitis B virus (HBV) infection in adults and adolescents (≥ 12 years and ≥ 35 kg body weight). The data included in the application support the use of TAF in treatment-naïve and treatment-experienced adults and adolescents with HBeAg-negative and HBeAg-positive HBV infection.

TAF is a novel, targeted prodrug of tenofovir that has demonstrated antiviral efficacy similar to and at one-tenth the dose of Gilead’s Viread® (tenofovir disoproxil fumarate, TDF) 245 mg. Data show that because TAF has greater plasma stability and more efficiently delivers tenofovir to hepatocytes compared to TDF, it can be given at a lower dose, resulting in less tenofovir in the bloodstream. As a result, TAF improved certain renal and bone laboratory safety parameters compared to TDF in clinical trials.

The CHMP’s recommendation will now be reviewed by the European Commission, which has the authority to approve medicines for use in the 28 countries of the European Union, Norway and Iceland.

The MAA for TAF includes data from two international Phase 3 studies (Studies 108 and 110) in 1,298 treatment-naïve and treatment-experienced patients with HBV infection. Study 108 randomized 425 HBeAg-negative patients to receive either TAF or TDF, and Study 110 randomized 873 HBeAg-positive patients to receive either TAF or TDF. The full data from Studies 108 and 110 were presented at the International Liver Congress™ (ILC) earlier this year.

TAF as a single-agent for HBV is an investigational product and its safety and efficacy have not yet been established.
More
Source: press release, 11/11/16. http://investors.gilead.com/phoenix.zhtml?c=69964&p=irol-newsArticle&ID=...

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